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Cadwell

by Xi'an Friendship Medical Electronics Co., Ltd. 53 variants

Ref 1311Model 302821-000-060

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-16955739013115 Basic UDI-DI 16955739013115UDI-DIDate12 Sep 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number16955739013115 UDI-DI Date14 Mar 2017ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Subdermal needle electrode
Device Name
Disposable Subdermal Needle Electrodes(Twisted)
Model / Reference
302821-000-060, 1311
Primary DI / UDI-DI
16955739013115
Basic UDI-DI
B-16955739013115
510(k) Number
FDA Product Code
GXZ
EMDN Code
Z121002 Nervous system monitoring systems
GMDN Term
Subdermal needle electrode
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
882.1350
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II
SterileEUDAMED
No
GUDID
Yes
Contains LatexEUDAMED
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
CN-MF-000004202
Authorised representative
Friendship Europe ApS DK-AR-000001593

Other devices from Xi'an Friendship Medical Electronics Co., Ltd.

See all devices from Xi'an Friendship Medical Electronics Co., Ltd. →

Properties

  • Sterile NoEUDAMEDYesGUDID
  • Single Use
  • Contains Latex YesEUDAMEDNoGUDID
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (15)

  • Implantable: No
  • Reusable: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No